ontario regulation 302/12
made under the
Pharmacy Act, 1991
Made: August 30, 2012
Approved: September 26, 2012
Filed: October 1, 2012
Published on e-Laws: October 1, 2012
Printed in The Ontario Gazette: October 20, 2012
Amending O. Reg. 202/94
(General)
1. Ontario Regulation 202/94 is amended by adding the following Part:
part vii.3
controlled acts
Interpretation
31. In this Part,
“adapt” means to change a patient’s prescription respecting,
(a) the dose of the prescribed drug,
(b) the dosage form of the prescribed drug,
(c) the directions for use of the prescribed drug, or
(d) the route of administration for taking the prescribed drug,
but does not include therapeutic substitution;
“Part A pharmacist” means a member who holds a certificate of registration as a pharmacist and who is listed in Part A of the register;
“prescriber” means a person who is authorized under the laws of a province or territory of Canada to give a prescription within the scope of his or her practice of a health profession;
“prescription” means a direction from a prescriber directing the dispensing of a drug or mixture of drugs for a specific patient;
“renew” means to provide a patient with a prescription that repeats a prescription previously provided to that patient;
“therapeutic substitution” means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent.
32. (1) Where the provisions of this Part are inconsistent with a law of Canada respecting prescriptions, including those related to a targeted substance, the law of Canada shall prevail and the provisions of this Part to the extent they are inconsistent with that law shall not apply.
(2) Where the provisions of this Part are inconsistent with the provisions of the Narcotics Safety and Awareness Act, 2010, the provisions of that Act shall prevail and the provisions of this Part, to the extent they are inconsistent with that Act, shall not apply.
Controlled Acts
33. A member shall not perform a controlled act under paragraph 2, 3, 4 or 5 of subsection 4 (1) of the Act except in accordance with this Part.
34. (1) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a member referred to in subsection (2) who meets all the requirements in subsection (3) is authorized to perform the following acts:
1. Administering a substance specified in Table 1 to this Regulation by injection to a patient.
2. Administering a substance specified in Table 2 to this Regulation by inhalation to a patient.
(2) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration.
(3) A member may only perform an act provided for in subsection (1) if he or she complies with the following:
1. The member may only perform the act for the purpose of patient education and demonstration, and before performing the act,
i. must explain that purpose to the patient or his or her authorized agent, and
ii. must receive an informed consent from the patient or his or her authorized agent.
2. The member shall ensure that he or she only performs the act in an environment that is clean, safe, private and comfortable for the patient.
3. The member shall ensure that appropriate infection control procedures are in place.
4. The member must possess sufficient knowledge, skill and judgment respecting the substance to be administered, and sufficient understanding of the condition of the patient, to be able to administer the substance safely.
5. The member must consider whether administering a substance by injection or inhalation to the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome after administration and any other relevant circumstances.
6. The member must maintain a patient record that includes,
i. the name and address of the patient,
ii. the name and address of the member,
iii. the date the act was performed,
iv. the name, strength (where applicable) and quantity of the substance that the member administered to the patient,
v. the circumstances relating to the administration of the substance to the patient and any adverse reaction experienced by the patient, and
vi. confirmation that an informed consent was given by the patient or his or her authorized agent.
(4) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a Part A pharmacist is authorized to administer influenza vaccine by injection to a patient who is five years of age or older, if the Part A pharmacist,
(a) administers the vaccine in accordance with Ontario’s Universal Influenza Immunization Program as described on the Ministry’s website;
(b) receives an informed consent from the patient or his or her authorized agent; and
(c) meets all the requirements in paragraphs 2 to 6 of subsection (3).
35. (1) For the purposes of paragraph 3 of subsection 4 (1) of the Act, a member referred to in subsection (3) who complies with the other requirements of this section is authorized to prescribe the following specified drugs:
1. Varenicline Tartrate.
2. Bupropion Hydrochloride.
(2) A drug mentioned in subsection (1) may only be prescribed by a member for the sole purpose of smoking cessation.
(3) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform the act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration.
(4) A member may only prescribe a drug under this section if he or she,
(a) possesses sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to prescribe the drug for the patient;
(b) has considered whether prescribing the drug for the patient is appropriate, given the known risks and benefits of prescribing the drug for the patient and other relevant factors respecting the patient;
(c) gives the prescription to the patient or his or her authorized agent;
(d) advises the patient or his or her authorized agent, at the time of giving the prescription, that he or she may elect to take it to a pharmacy of his or her choosing for dispensing;
(e) notifies the patient’s primary care provider (if any) within a reasonable time, that the member prescribed a drug for the patient and provides details respecting the prescription; and
(f) complies with the additional requirements under sections 37 and 38.
36. (1) For the purposes of paragraph 4 of subsection 4 (1) of the Act, a member referred to in subsection (3) who complies with the other provisions of this section is authorized to perform the following acts:
1. Adapting a patient’s prescription.
2. Renewing a patient’s prescription for the purpose of continuity of care.
(2) Subsection (1) does not authorize a member referred to in subsection (3) to adapt or renew a prescription for a controlled substance as defined in the Controlled Drugs and Substances Act (Canada) or a drug designated as a monitored drug by the regulations under the Narcotics Safety and Awareness Act, 2010.
(3) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration.
(4) A member may only perform an act provided for in subsection (1) if he or she complies with the following:
1. The member must either possess the patient’s prescription to be adapted or renewed or,
i. receive a copy of the prescription directly from the pharmacy where the prescription was dispensed to the patient,
ii. be satisfied based on verbal confirmation from a pharmacist at the pharmacy where the prescription was dispensed to the patient as to the existence and details of the prescription, or
iii. have access to the medical record that contains information about the prescription.
2. If the member is renewing a prescription, he or she must not prescribe a quantity of the drug that exceeds the lesser of,
i. the quantity that was originally prescribed, including any refills that were authorized by the prescriber, and
ii. a six months’ supply.
3. The member must, within a reasonable time, notify the prescriber identified on the prescription adapted or renewed by the member, as well as the patient’s primary care provider if the member knows that the patient has such a care provider other than the prescriber, providing details about the patient’s prescription, when the member,
i. renews a patient’s prescription, or
ii. adapts a patient’s prescription, if, in the member’s opinion,
A. adapting the prescription is clinically significant in relation to the patient, or
B. the notification is necessary to support the patient’s care.
4. At the time that the member adapts or renews the patient’s prescription, the member must advise the patient or his or her authorized agent,
i. that he or she is entitled to the prescription, and
ii. that he or she may take the prescription to a pharmacy of his or her choosing for dispensing.
5. The member must comply with the additional requirements under sections 37 and 38.
37. A member who performs an act provided for in section 35 or 36 must ensure that the following information is recorded on the prescription:
1. The name and address of the patient for whom the drug is prescribed.
2. The name, strength (where applicable) and quantity of the prescribed drug.
3. Directions for the use of the drug, including its dose, frequency, route of administration and any special instructions.
4. The name, address, telephone number and College registration number of the member issuing the prescription.
5. The date the prescription was issued by the member.
6. If applicable, reference to the prescription that the member adapted or renewed, including the name and contact details of the original prescriber.
7. The number of refills that the member authorized, if applicable.
8. Any other information required by law.
38. A member who performs an act under section 35 or 36 must maintain a patient record that includes details of the member’s rationale for his or her decision to act under section 35 or 36 and the following information, if applicable:
1. Reference to, or a copy of, the patient’s prescription that the member renewed or adapted, including the name and contact information of the prescriber.
2. A copy of the prescription that the member gave to the patient or his or her authorized agent under clause 35 (4) (c) or that the member gave to the patient or his or her authorized agent to take to a pharmacy of their choosing under paragraph 4 of subsection 36 (4).
3. A record of the results of laboratory or other tests that the member considered in making the decision to act under section 35 or 36.
4. The date on which the member notified the following persons, as applicable, and the method by which the notification occurred:
i. The patient’s primary care provider notified under clause 35 (4) (e) or paragraph 3 of subsection 36 (4).
ii. The patient’s prescriber notified under paragraph 3 of subsection 36 (4).
39. (1) For the purposes of paragraph 5 of subsection 4 (1) of the Act, a member referred to in subsection (2) who meets all the requirements in subsection (4) is authorized to perform the act of piercing a patient’s dermis with a lancet-type device to obtain blood.
(2) A member who is a Part A pharmacist, an intern, a registered pharmacy student or a pharmacy technician is authorized to perform the act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration.
(3) A pharmacy technician shall not perform the act provided for in subsection (1) unless,
(a) a Part A pharmacist is physically present on the premises at the time when the pharmacy technician performs the act; and
(b) the pharmacy technician is under the direction of a Part A pharmacist at the time when the pharmacy technician performs the act.
(4) A member may only perform the act provided for in subsection (1) if he or she complies with the following:
1. The member may only perform the act for the purpose of demonstrating the appropriate use of lancet-type devices for the patient’s self care and education or for the patient’s self monitoring of his or her chronic disease, and before performing the act,
i. shall explain that purpose to the patient or his or her authorized agent, and
ii. shall receive an informed consent from the patient or his or her authorized agent.
2. The member shall ensure that he or she only performs the act in an environment that is clean, safe, private and comfortable for the patient.
3. The member shall ensure that appropriate infection control procedures are in place.
4. The member must possess the knowledge, skill and judgment respecting the performance of the act and understand the condition of the patient, to perform it safely and effectively.
5. The member must consider whether performing the act on the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome and any other relevant circumstances.
6. The member must maintain a patient record that includes,
i. the name and address of the patient and the member,
ii. the date the act was performed, and
iii. confirmation that an informed consent was given by the patient or his or her authorized agent.
2. The Regulation is amended by adding the following Tables:
Table 1
Column 1
Column 2
Column 3
Column 4
American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classification
Substance
8:00 Anti-infective Agents
8:18 Antivirals
8:18.08.04 HIV Entry and Fusion Inhibitors
Enfuvirtide
8:18.20 Interferons
Interferon Alfa-2b
Peginterferon alfa-2a
Peginterferon alfa-2b
10:00 Antineoplastic Agents
Goserelin
Leuprolide
Methotrexate
12:00 Autonomic Drugs
12:12 Sympathomimetic (Adrenergic) Agents
12:12.12 Alpha- and Beta-Adrenergic Agonists
Scopolamine
Hyoscine
Glycopyrrolate
Epinephrine
20:00 Blood Formation and Coagulation
20:04 Antianemia Drugs
20:04.04 Iron Preparations
Iron
20:12 Coagulants and Anticoagulants
20:12.04 Anticoagulants
Dalteparin
Danaparoid
Enoxaparin
Fondaparinux
Heparin
Nadroparin
Tinazaparin
20:16 Hematopoietic Agents
Ancestim
Darbepoetin alfa
Epoetin alfa
Filgrastim
Pegfilgrastim
Romiplostim
28:00 Central Nervous System Agents
28:08 Analgesics and Antipyretics
28:08.08 Opiate Agonists
Codeine
Hydromorphone
Meperidine
Morphine
28:08.12 Opiate Partial Agonists
Nalbuphine
Pentazocine
28:16 Psychotherapeutic Agents
28:16.08 Antipsychotics
Haloperidol
Methotrimeprazine
28:32 Antimigraine Agents
28:32.28 Selective Serotonin Agonists
Sumatriptan
40:00 Electrolytic, Caloric, and Water Balance
40:12 Replacement Preparations
Normal saline
48:00 Respiratory Tract Agents
48:92 Respiratory Tract Agents, Miscellaneous
Omalizumab
56:00 Gastrointestinal Drugs
56:22 Antiemetics
56:22.08 Antihistamines
Dimenhydrinate
Prochlorperazine
56:32 Prokinetic Agents
Metoclopropamide
56:92 GI Drugs, Miscellaneous
Certolizumab Pegol
Methylnaltrexone
64:00 Heavy Metal Antagonists
Deferoxamine
68:00 Hormones and Synthetic Substitutes
68:18 Gonadotropins
Follitropin-alpha
Follitropin-beta
Gonadotropin-chorionic
Gonadotropin-chorionic-alfa
Gonadotropin-human
Lutropin-alfa
Menotropins
Urofollitropin
68:20 Antidiabetic Agents
Exenatide
Insulins
Liraglutide
68:22 Antihypoglycemic Agents
68:22:12 Glycogenolytic Agents
Glucagon
68:24 Parathyroid
Calcitonin Salmon
Teriparatide
68:28 Pituitary
Desmopressin
Vasopressin
68:30 Somatotropin Agonists and Antagonists
68:30.04 Somatotropin Agonists
Somatropin
68:30.08 Somatotropin Antagonists
Pegvisomant
68:32 Progestins
Medroxyprogesterone
88:00 Vitamins
88:08 Vitamin B Complex
Cyanocobalamin
Folic Acid
Methylcobalamin
Pyridoxine
Thiamine
88:12 Vitamin C
Ascorbic Acid
88:24 Vitamin K Activity
Vitamin K
92:00 Miscellaneous Therapeutic Agents
92:12 Antidotes
Leucovorin
92:20 Biologic Response Modifiers
Denosumab
Glatiramer
Interferon-Beta-1A
Interferon-Beta-1B
Natalizumab
92:36 Disease-modifying Antirheumatic Drugs
Abatacept
Adalimumab
Anakinra
Etanercept
Gold Sodium Thiomalate
Golimumab
Ustekinumab
92:40 Gonadotropin- releasing Hormone Antagonists
Cetrorelix
Ganirelix
92:92 Other Miscellaneous Therapeutic Agents
Octreotide
Miscellaneous
Sterile Water for Injection (Diluent)
Table 2
Column 1
Column 2
Column 3
Column 4
American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classification
Substance
8:00 Anti-infective Agents
8:18 Antivirals
8:18.28 Neuraminidase Inhibitors
Zanamivir
8:12 Antibacterials
8:12.07.16 Monobactams
Tobramycin
Aztreonam
12:00 Autonomic Drugs
12:08 Anticholinergic Agents
12:12.08 Antimuscarinics/Antispasmodics
Ipratropium
Tiotropium
12:12 Sympathomimetic (Adrenergic) Agents
12:12.08.12 Selective Beta2- Adrenergic Agonists
Fenoterol
Formoterol
Salbutamol
Salmeterol
Terbutaline
12:16 Sympatholytic (Adrenergic Blocking) Agents
12:16.04.04 Non-Selective alpha-Adrenergic Blocking Agents
Dihyroergotamine
12:92 Autonomic Drugs, Miscellaneous
Nicotine
28:00 Central Nervous System Agents
28:08 Analgesics and Antipyretics
28:08.12 Opiate Partial Agonists
Butorphanol
28:32 Antimigraine Agents
28:32.28 Selective Serotonin Agonists
Sumatriptan
Zolmitriptan
40:00 Electrolytic, Caloric, and Water Balance
40:12 Replacement Preparations
Sodium chloride
48:00 Respiratory Tract Agents
48:24 Mucolytic Agents
Dornase alfa
52:00 Eye, Ear, Nose and Throat (EENT) Preparations
52:02 Antiallergic Agents
Sodium Cromoglycate
Levocabastine
52:08 Anti-inflammatory Agents
52:08.08 Corticosteroids
Beclomethasone
Budesonide
Ciclesonide
Flunisolide
Fluticasone
Mometasone
Triamcinolone
52:32 Vasoconstrictors
Oxymetazoline
Phenylephrine
Xylometazoline
68:00 Hormones and Synthetic Substitutes
68:18 Gonadotropins
Buserelin
Nafarelin
68:24 Parathyroid
Calcitonin Salmon
68:28 Pituitary
Desmopressin
Vasopressin
92:00 Miscellaneous Therapeutic Agents
92:12 Antidotes
Acetylcysteine
Commencement
3. This Regulation comes into force on the day it is filed.
Made by:
Council of the Ontario College of Pharmacists:
Sherif Guorgui
President
Marshall Moleschi
Registrar
Date made: August 30, 2012.
